AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Launched by ASTRAZENECA · Nov 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AZD0486 for patients with B-cell Acute Lymphoblastic Leukemia (B-ALL) who have not responded to previous therapies. The trial is in its early phases and aims to find out how safe this treatment is, how well it works, and the best dose to use. It involves three parts: the first part will gradually increase the dose of AZD0486 to find the right amount, the second part will focus on optimizing that dose, and the third part will look at how well this dose works in a larger group of patients.

To participate in this trial, you need to be at least 16 years old (or 12 years old in some parts) and have been diagnosed with B-ALL that has relapsed or has not responded to treatment. You must also have a certain percentage of leukemia cells in your bone marrow and cannot have certain complications, like active involvement of the central nervous system. If you join the trial, you can expect regular check-ups and monitoring to assess your health and how well the treatment is working. This trial is currently recruiting participants, so if you or someone you know might be eligible, it could be a chance to access a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: 12 years and above (Parts A, B and C).
• * Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with:
• • 1. Bone marrow infiltration with \>/= 5% blasts
• • 2. Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option.
• • 3. Philadelphia positive participants are allowed in Part A if intolerant or refractory to TKIs.
• • For participants older than 16 years, Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. For Participants 16 years or younger, Lansky score more or equal to 50%.
• • The above is a summary, other inclusion criteria details may apply.
• Exclusion Criteria:
• • Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria).
• • Isolated extramedullary disease relapse.
• • Testicular leukemia
• • History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; or prior Grade 4 neurotoxicity with CAR-T or TCE therapy.
• • History of other malignancy (with certain exceptions).
• • Unresolved AEs \>/= Grade 2, from prior therapies
• • Prior therapy with TCEs within 4 weeks, CAR T-cell therapy or autologous HSCT within 8 weeks or prior alloSCT within 12 weeks of start of therapy.
• • GVHD requiring immunosuppressive therapy within 3 weeks prior to AZD0486 treatment.
• • The above is a summary, other exclusion criteria details may apply.